American Family Pharmacy, LLC
Amended 483 issued July 21, 2014 · Indianapolis, Indiana
- Inspection
- Jun 11 – Jul 8, 2014
- Investigator
- Robert M. Harbos
- Observations
- 13
- Pages
- 12
- FEI number
- 3004971302
In short: On July 21, 2014, FDA issued a Amended 483 with 13 observations to American Family Pharmacy, LLC in Indianapolis, Indiana (FEI 3004971302) after an inspection that ran Jun 11 – Jul 8, 2014. The investigator was Robert M. Harbos. Most observations concern quality system and materials.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
Batch production and control records do not include complete information relating to the production and…
- 02
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 03
Employees are not given training in the particular operations they perform as part of their function…
- 04
Drug product production and control records, are not reviewed and approved by the quality control unit…
9 more observations
Plus the full detail behind each one, exactly as FDA wrote it.
Get the full amended 483This inspection in context
Robert M. Harbos
1 document · 2014
Cites 211.110(a) (sampling and testing of in-process materials and drug products) more than any other section. Most of their documents are for sites in Indiana.
The firmAmerican Family Pharmacy, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar documentsOther sites cited under 211.188
See how FDA wrote the same problem up elsewhere.
Questions about this amended 483
What did FDA find at American Family Pharmacy, LLC?
FDA listed 13 observations on this Form 483, mostly about quality system, materials and laboratory controls. The opening words of each observation are shown on this page.
Who inspected American Family Pharmacy, LLC?
Robert M. Harbos is named on this Amended 483, for the inspection of Jun 11 – Jul 8, 2014. Each investigator has a profile showing what they cite most.
When was American Family Pharmacy, LLC inspected by FDA?
The inspection ran Jun 11 – Jul 8, 2014, and the Amended 483 is dated July 21, 2014.
How do I get the full Amended 483 for American Family Pharmacy, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.